India focuses on cell therapy regulation as FDA’s Hamburg wraps up trip

India focuses on cell therapy regulation as FDA’s Hamburg wraps up trip
India focuses on cell therapy regulation as FDA’s Hamburg wraps up trip

Related tags Stem cell Food and drug administration

As US FDA Commissioner Margaret Hamburg finishes her trip through India, the country is now shifting its focus to the regulation of stem cell and other cell therapies.

In a note to pharma companies​ released Monday, CDSCO (Central Drugs Standards Control Organization) re-iterates that it has created a committee to regulate the manufacturing of stem cell and other cell therapies.

The Committee, chaired by Lalji Singh, submitted its report on stem cell and other cell therapies and will soon issue a draft document detailing technical and organizational aspects for how the regulations will be set up and how it will be operated by CDSCO.

The Ministry of Health and Family Welfare have instructed the DCGI (Drugs Controller General of India) to “take urgent steps to ensure the recommendations of the Committee are implemented at the earliest​” time.

CDSCO also recently issued draft guidance on the manufacture of large volume parenterals​.

The announcement comes as Hamburg wraps up her trip to the subcontinent, which according to one media outlet​, seems to have gotten more difficult for her.

The FDA has said it will increase its number of manufacturer inspectors in the country to 18, though supply chain and clinical trial​ issues have long plagued the agency’s regulation of Indian pharmaceuticals. The US FDA did not respond to a request for comment on Hamburg’s trip.

Related topics Markets & Regulations Cell lines

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